CroíValve Expands Series B Financing With $27 Million Additional Capital

CroíValve has closed $20 million in Series B expansion financing, along with $7 million European Innovation Council (EIC) and DTIF grant financing. The additional funding brings the Series B total to $36 million, and $43 million, including grant money.

The financing involved new investors BGF and EIC, as well as current investors, including the MedTech Syndicate. CroíValve has welcomed Tim Rea, co-head of early-stage investments at BGF, to its Board of Directors.

Proceeds from the financing will be used to fund an expanded TANDEM II study, a U.S. and EU-based prospective, multicenter trial to evaluate the safety and performance of the DUO Adapt System in patients with severe or greater symptomatic tricuspid regurgitation (TR). This study is being expanded beyond the 15 patients already treated to include additional U.S. and European sites.

The DUO System is a novel transcatheter heart valve that preserves the patient’s native anatomy while treating TR. It works in tandem with the native tricuspid valve to restore valve function while avoiding contact with critical structures in the right heart that could lead to complications. Designed to treat the heterogeneity of the TR patient population, this includes patients who cannot always be treated by other transcatheter therapies. It enables a straightforward procedure to reduce the procedural and imaging complexity seen with other devices. The technology includes a coaptation valve that is positioned between the tricuspid valve leaflets to prevent blood from flowing backward. The DUO Adapt System includes optimization of the coaptation valve to fill larger, complex leaks by adapting to the patient’s individual leak shape, introducing a new category in treating TR known as Adaptive Coaptation. Promising early clinical use with the DUO Adapt System highlights the ability to treat very large leaks, up to 35mm, with significant reduction in TR.

“The team’s commitment to finding solutions to a major clinical problem is impressive, treating a debilitating disease without the need to resort to invasive surgery,” Rea said. “CroíValve’s differentiated technology positions it well to address a large and growing market for structural heart devices, and we’re excited to partner with them as they accelerate the trials and testing process.”

Tricuspid regurgitation is a severe heart condition that occurs when the tricuspid valve in the heart’s right side fails to close properly. Recently highlighted as the most prevalent valve disease, 3.7% of people over 65 develop moderate or greater TR. It affects more than 4 million people in Europe and the United States and is associated with significant symptoms and reduced life expectancy.

“Healthcare innovation matters most when it helps address challenges that affect millions of people. CroíValve is developing a novel approach to treating a serious heart condition that remains difficult to manage with existing therapies, particularly for patients who aren’t suitable candidates for invasive surgery. This is precisely the kind of breakthrough innovation the EIC supports: technologies with the potential to improve quality of life, strengthen Europe’s medical technology leadership and deliver meaningful societal impact,” EIC Fund Board member Hermann Hauser stated.

CroíValve is a clinical stage medical device company developing a transcatheter device for treating tricuspid regurgitation, with research, development, and operations based in Ireland, and clinical and regulatory services based in the United States.

The DUO System is an investigational device and not for sale in any geography.

BGF has invested £5 billion in 650 businesses since 2011. It provides flexible capital as a minority equity partner. Initial investments in growth-stage business are between £3 million and £30 million, and between £3 million and £10 million for earlier-stage businesses. BGF provides follow-on funding to support further growth, and tailored value creation support from investment to exit.

The European Innovation Council Fund from the European Commission is a deep tech investor across all technologies. The EIC Fund aims to fill a critical financing gap to support companies developing and commercializing disruptive technologies. With its large network of capital providers and strategic partners, it shares risk and crowds in market players.

Medtech Syndicate is an Irish-based syndicate dedicated to fostering innovation within the medical technology ecosystem. Founded in 2014 by seasoned entrepreneurs and former leaders from medtech companies such as Medtronic, Boston Scientific, Abbott, and Creganna. It specializes in investing in medical devices, hardware, and diagnostic technologies. Medtech Syndicate has supported CroíValve since 2018.